# K250088: FlowTriever2 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Inari Medical, Inc.
- Decided: Mar 13, 2025 after 58 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K832023 (1983). 18 ancestors in all.
No later device cites it as a predicate yet.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201541: FlowTriever Retrieval/Aspiration System, Inari Medical (2020) Summary page 5.

## Indications for use
The FlowTriever2 Catheter is indicated for: • The non-surgical removal of emboli and thrombi from peripheral blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).

Source page: https://510kreport.com/device/K250088
Methodology: https://510kreport.com/methodology